Slapped with the most severe post-inspection classification, the state of Novo Nordisk’s Indiana manufacturing site could pose a problem for clients, including Regeneron and Scholar Rock.
Nabla and Takeda first joined hands in 2022, to push “the boundaries of next-generation biologics discovery,” according to the startup’s CEO Surge Biswas.
Regeneron is aiming to file a regulatory application for DB-OTO by the end of the year.
The last few months have been tumultuous for the CDC, which has seen the ouster of Director Susan Monarez and all 17 members of the Advisory Committee on Immunization Practices.
Moderna’s mRNA-4359, when used with Keytruda, achieves a 24% overall objective response rate in patients with melanoma, with efficacy increasing to 67% in those positive for PD-L1.
Novo had around 250 employees working on cell therapies, all of whom will be laid off, though a spokesperson declined to reveal which offices and locations will be affected.
FEATURED STORIES
After spinning out of BridgeBio in May 2024, BBOT had an eye on another round of fundraising in 2025. A SPAC quickly emerged as the best option.
Aside from the rare disease market, Novo Nordisk also scored a key regulatory win last month for its blockbuster GLP-1 drug Wegovy, which can now be used to treat patients with metabolic dysfunction-associated steatohepatitis.
After a demoralizing period punctuated by the withdrawal of one of the few marketed therapies for ALS, investment in new biotechs, state-backed collaborative initiatives and buzz at BIO2025 suggest a new day in drug development for one of medicine’s most intractable diseases.
With a flurry of recent Big Pharma investment in radiopharmaceutical therapeutics, the FDA issued draft guidance last month in a move former FDA Commissioner Stephen Hahn sees as the regulator “trying to get ahead on a new set of therapy that they see becoming very important for cancer.”
While trade groups hail the executive order as a national health security opportunity, analysts warn that production costs could go up in the near term.
During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same.
LATEST PODCASTS
In this episode presented by Eclipsebio, BioSpace’s head of insights Lori Ellis discusses mRNA and srRNA with Andy Geall of Replicate Bioscience and Alliance for mRNA Medicines, and Pad Chivukula of Arcturus Therapeutics.
H2 2025 catalysts to watch, biopharma implications of President Trump’s tax law, KalVista’s new hereditary angioedema drug that Marty Makary reportedly tried to reject, another lawsuit aimed at Health Secretary Robert F. Kennedy Jr. and a plea from patients with ALS for access to BrainStorm’s NurOwn.
The high court sides with HHS on HIV PrEP drugs; Health Secretary RFK Jr.’s newly appointed CDC vaccine advisors discuss thimerosal in flu vaccines, skip vote on Moderna’s mRNA-based RSV vaccine; FDA removes CAR T guardrails; AbbVie snaps up Capstan for $1.2B to end first half; and psychedelics take off again with data from Compass and Beckley.
Job Trends
Less than two months after two FDA-related setbacks, Atara Biotherapeutics is again cutting its workforce in half. This time, it’s also hitting pause on two CAR T programs, including one affected by an FDA clinical hold in January.
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SPECIAL EDITIONS
In this deep dive, BioSpace explores the next big thing in obesity.
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
DEALS
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BioNTech said in 2022 that it faced “threats of a groundless patent infringement suit” from a company that was “unable to bring to market any product to help in the fight against COVID-19.” Now, the mRNA biotech is buying that very company. -
Sanofi paid a more than 300% premium on its acquisition of Vigil Neuroscience, suggesting a fierce battle to seal the deal. Across biopharma, companies are sometimes willing to put it all on the line for the right buyout. Novartis’ recent acquisition of Regulus for $800 million upfront provides a case study. -
The pending deal was rumored overnight after a report from the Financial Times, spurring analysts to speculate that if true, the entire gene editing space would see a boost at the markets. -
Big Pharma executives have not been shy about their desire for deals, but companies have been battling macro headwinds alongside Trump’s policies on drug pricing and tariff threats. -
At a satellite kickoff event to the annual BIO meeting, investment bankers and VCs gave reasons for optimism amid a ‘volatile’ period for the industry.
WEIGHT LOSS
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George Tidmarsh takes over temporarily at CBER following Vinay Prasad’s abrupt departure; Replimmune trial leaders protest rejection reportedly driven by FDA’s top cancer regulator Richard Pazdur; Merck’s $3 billion savings push claims 6,000 jobs; and Pfizer CEO Albert Bourla addresses President Donald Trump’s new threats around Most Favored Nation drug pricing. -
Earlier this year, the Centers for Medicare and Medicaid Services scrapped a previous proposal, from the Biden administration, to include anti-obesity medications in Medicare Part D coverage. -
Roche obtained CT-173, a PYY mimetic, in its $2.7 billion acquisition of Carmot Therapeutics in December 2023. The company reported the change in its second quarter earnings call. -
A retrospective cohort study found that semaglutide and tirzepatide are linked with significantly lower risks of dementia and stroke, hinting at potential neuroprotective effects of GLP-1 therapies. -
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees and tying review times to drug prices; the regulator opens its trove of complete response letters in the name of transparency; and two companies receive rejections for rare disease therapies.
POLICY
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The CDC director—the first to be confirmed by the Senate under new legislation—has been ousted after less than a month following internal unrest regarding new, more restrictive approvals for updated COVID-19 vaccines, according to multiple sources. -
Scott Gottlieb, who served as FDA commissioner during the first Trump administration, wrote in a JAMA editorial that China is speeding drugs to market and could potentially surpass the U.S. in the innovation game. -
The MIT professor of management, who already sits on the CDC’s revamped immunization advisory committee, is a known skeptic of vaccines, particularly mRNA technology. -
The White House has denied reports that the government could soon ban COVID-19 vaccines, noting that in the absence of an official announcement, “any discussion about HHS policy should be dismissed as baseless speculation.” -
Thousands of employees across the Department of Health and Human Services are set to lose their collective bargaining rights in a move that American Federation of Government Employees national president Everett Kelley called “illegal and immoral.”
A BioSpace LinkedIn poll showed that just 19% of respondents believe biopharma professionals need Ph.D.s for scientist roles.
Employers have adjusted to higher salaries. That also means they’ve become adamant they get specific skill sets, according to Greg Clouse, BioSpace recruitment manager.
Looking for a job in Texas? Check out these nine companies hiring life sciences professionals like you.
Whether they’re newly minted managers or C-suite executives, effective managers often lead with empathy, intellectual curiosity and vulnerability.
Generative AI could enhance and accelerate the way people work on clinical trials. In this Q&A, a management consultant shares his insights on benefits, risks and more.
While many describe California as having a tough life sciences market, there’s some optimism that employment opportunities will improve soon, according to California Life Sciences President and CEO Mike Guerra.
HOTBEDS
REPORTS
BioSpace surveyed industry employers and professionals to understand what to expect from the recruitment market in 2022. What do professionals want? How difficult will it be to recruit new talent?
Get up to speed with BioSpace’s data with up-to-date info about retention, layoffs, “quiet quitting” and projections for 2023.
After a tumultuous 2022, life science employers are settling into their hiring goals for 2023. Though they may be hiring at lower volume, the majority of organizations are still actively recruiting.
CANCER
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In an open letter, 22 experts who designed and ran Replimune’s Phase III IGNYTE trial answered the FDA’s issues, as outlined in the complete response letter for the melanoma candidate RP1. -
According to reporting from multiple outlets, Richard Pazdur, head of the Oncology Center of Excellence at CDER, opposed the consensus opinion of CBER staff to approve the drug. Replimune’s stock has dropped precipitously since the rejection. -
The company expects that the U.S. COVID-19 vaccination rate will be “maybe a couple of points lower” than the prior level of around 20% but that pricing and Comirnaty’s market share will hold steady. -
The pivotal Phase II trial is testing Allogene’s CAR T candidate cemacabtagene ansegedleucel for large B-cell lymphoma. ALLO-647 was being used as a preparative lymphodepletion therapy. -
After decades of limited progress—owing to the difficulty of treating the disease and resultant market risk—glioblastoma research is entering a new phase spurred by smarter trials, targeted funding and renewed interest from companies like Merck and Jazz Pharmaceuticals.
NEUROSCIENCE
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Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug regulator in George Tidmarsh, a handful of new drugs get turned away from the market and pharma companies continue to commit billions to reshoring manufacturing.
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Otsuka and Lundbeck’s data are insufficient to establish significant efficacy of Rexulti plus sertraline in PTSD, according to the FDA’s outside experts. -
The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute liver failure, the same complication responsible for the deaths of two boys taking Sarepta’s Duchenne muscular dystrophy treatment Elevidys. -
FDA reviewers flag “discordant results” in a briefing document published ahead of Friday’s advisory committee meeting for the partners’ application for the antipsychotic in post-traumatic stress disorder. -
Participants in trials of BrainStorm Cell Therapeutics’ NurOwn filed a Citizens’ Petition with the FDA earlier this month seeking a new review of the stem cell therapy that was rejected in 2022 based on real-world data and 90% survival in an expanded access program.
CELL AND GENE THERAPY
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The strategic reprioritization comes after the company hit two major hurdles in the past year, including a clinical hold for an investigational gene therapy and an FDA rejection for its lead asset. -
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an anonymous senior FDA official. Given Elevidys’ full approval, however, experts told BioSpace this path would set up a length legal battle between the regulator and Sarepta Therapeutics. -
Second-quarter earnings come amid many high-level challenges for the biopharma industry. How will these five closely watched biotechs fare? -
Dispatch seeks to address two main challenges of immunotherapies in solid tumors: the lack of a target and the immunosuppressive tumor environment. -
The voluntary pauses follow two patient deaths associated with the Duchenne muscular dystrophy gene therapy.
